DSEGlossary

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HCLS IG, Drug Safety and Efficacy Task Force Glossary

  • Biomarkers: A biological characteristic that is objectively measured and evaluted as an indicator of normal biological or pathologenic processes or pharmacological responses to a therapeutic intervention; these can be obtained from microarray analysis, protein assays, or even clinical signs. (see FDA definition and EMEA definition)
  • Pharmacogenomics: The branch of pharmaceutics which deals with the influence of genetic variation on drug response, efficacy or toxicity.
  • Bench-to-Bedside: A proposed vision for healthcare research that would accelerate the development of new treatements through more direct use of R&D knowledge.
  • Translational medicine: A proposed vision of Drug R&D that fosters better association of animal and human studies in order to make better decision in the development process taht would reduce costs and increase time-to-market.
  • Safety Signals: Any solid indicators that can provide early warning to adverse drug reactions.
  • Pharmacovigilance: The pharmacological practice of the detection, assessment and prevention of adverse effects, particularly long term and short term side effect, through the monitoring and analysis of data, even after a product hase been launched (Postmarketing pharmacovigilance). For more info see http://en.wikipedia.org/wiki/Pharmacovigilance